A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer

JRCT ID: jRCTs032180154

Registered date:25/02/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 22/05/2018
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Carbon-ion radiotherapy for breast tumor (no tumor resection). Adjuvant therapy is performed based on the guidelines for breast cancer.

Outcome(s)

• Primary Outcome: Adverse reaction of normal tissue within 90 days after starting of the treatment.

Secondary Outcome

1. Adverse reaction of normal tissue in late phase
2. Local effect (CR rate)
3. Local control rate with recommended dose
4. Breast cosmetic outcomes
5. Progression-free survival period
6. Overall survival period

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ.
2. Tumor size <=20 mm on MRI.
3. No massive LVSI or EIC.
4. No lymphenode metastasis (>2 mm). Sentinel lymph node biopsy is performed prior this study.
5. No distant metastasis.
6. Performance status (ECOG) of 0 to 2.
7. 20 years old or older.
8. A life expectancy of at least 6 months.
9. Written informed consent.

Exclude criteria

1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease).
2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side.
3. Active other malignancy
4. The distanse between skin surface and tumor (including EIC) <=5 mm.
5. Previous radiation therapy for breast cancer in same side.
6. Eligible patients for "Breast cancer I" or "Breast cancer III".
7. Pregnancy, pregnancy potential.
8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.

Related Information

• Primary Sponsor: Karasawa Kumiko
• Secondary ID(s): UMIN000029478